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Last Updated: March 29, 2024

Bepotastine besilate - Generic Drug Details


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What are the generic sources for bepotastine besilate and what is the scope of patent protection?

Bepotastine besilate is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Mylan, and Bausch And Lomb Inc, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bepotastine besilate has eleven patent family members in eight countries.

There are seven drug master file entries for bepotastine besilate. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for bepotastine besilate

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Recent Clinical Trials for bepotastine besilate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Laboratorios PoenPhase 4
Laboratorios Sophia S.A de C.V.Phase 1
Dong-A ST Co., Ltd.N/A

See all bepotastine besilate clinical trials

Generic filers with tentative approvals for BEPOTASTINE BESILATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1.5%SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bepotastine besilate
Paragraph IV (Patent) Challenges for BEPOTASTINE BESILATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BEPREVE Ophthalmic Solution bepotastine besilate 1.5% 022288 3 2013-09-09

US Patents and Regulatory Information for bepotastine besilate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 214588-001 Apr 5, 2023 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb Inc BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288-001 Sep 8, 2009 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Apotex BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 206066-001 Mar 5, 2019 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 206220-001 Mar 18, 2019 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for bepotastine besilate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb Inc BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288-001 Sep 8, 2009 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb Inc BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288-001 Sep 8, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for bepotastine besilate

Country Patent Number Title Estimated Expiration
South Korea 101016595 ⤷  Try a Trial
Japan 3631748 ⤷  Try a Trial
Austria 528003 ⤷  Try a Trial
Spain 2371340 ⤷  Try a Trial
Japan WO2004011001 水性液剤および光安定化された水性液剤 ⤷  Try a Trial
China 1612734 Aqueous liquid preparations and light-stabilized aqueous liquid preparations ⤷  Try a Trial
Australia 2003252746 AQUEOUS LIQUID PREPARATIONS AND LIGHT-STABILIZED AQUEOUS LIQUID PREPARATIONS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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